European Society of Cardiology
Skip navigation links
Home
About the ESC
Membership
Communities
Congresses
Education
Guidelines & Surveys
Journals
Initiatives
Welcome to the European Society of Cardiology. Our mission: to reduce the burden of cardiovascular disease in Europe
 

Intra-aortic balloon pumps do not reduce infarct size in patients with STEMI without cardiac shock: the CRISP AMI trial 

Hot Line III - Acute Coronary Syndromes

Topics: Acute Coronary Syndromes (ACS)
Date: 30 Aug 2011
Paris, France, 30 August: Intra-aortic balloon pump counterpulsation prior to PCI in patients with ST segment elevation MI does not reduce infarct size as measured by MRI, according to results from the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction (CRISP AMI) trial.

Intra-aortic balloon counterpulsation is a procedure in which a balloon inserted in the aorta is timed to inflate at the start of diastole and to deflate before the start of systole. This increases diastolic pressure, which increases coronary perfusion and oxygen delivery to the myocardium, and facilitates ejection of blood from the left ventricle. There is evidence that LV unloading before reperfusion can reduce the extent of the infarct; infarct size has been shown to predict LV function after AMI.

Principal investigator Dr Manesh Patel from the Duke Clinical Research Institute of Duke University, Durham, USA, explained: "Animal studies had suggested that inserting a balloon pump before opening the vessel would reduce the heart’s workload and, by doing so, could potentially reduce infarct size. However, having tested this observation in humans, we did not show similar results.”

CRISP AMI was a multicentre, prospective, randomised trial in patients with acute ST segment elevation MI without shock. They were recruited within six hours of chest pain onset and planned primary PCI. Of the 337 patients enrolled, 161 were randomised to receive intra-aortic balloon counterpulsation (IABC) prior to primary PCI, and 176 to standard care (SOC, primary PCI without IABC support).

The primary efficacy endpoint of the trial was infarct size measured by cardiac MRI at 3-5 days post-PCI. The secondary clinical endpoint was the composite of major adverse clinical events including death, reinfarction, and heart failure at six months.

Results showed that mean infarct size was not significantly different between the IABC and SOC groups (42.1% vs. 37.5%, representing the percentage of left ventricle affected). At 30 days, major bleeding or transfusion had occurred in five (3.1%) of IABC patients and three (1.7%) of SOC patients. Major vascular complications occurred in seven IABC (4.3%) and two SOC (1.1%) patients. By six months, death had occurred in three (1.9%) of the IABC and nine (5.2%) of the SOC group.

While the study did not meet its primary endpoint, and was not powered to draw significant conclusions on clinical events, Dr Patel says the results nevertheless offer an insight into the treatment of STEMI patients. “The most striking observation is the excellent overall outcome for the highest risk patients within the context of this trial,” he says. “The IABC group had less than 5% mortality, and it’s difficult to improve that. We’ve become very good at treating AMI patients.” In the USA acute mortality risk in AMI is between 6% and 15%; one-year mortality is estimated at 38% for women and 25% for men.


Conclusion Dr Patel adds that 15 of the patients in the SOC group crossed over to receive IABC, and five patients crossed over prior to PCI and ten patients after PCI. “While this trial shows that the routine use of IABC cannot be recommended in STEMI, physicians should be vigilant about identifying those patients who are at risk for rapid deterioration and may benefit from counterpulsation,” he says.

Authors: Doctor Patel, Manesh (Durham, USA)

ESC Press Office

For background information, please contact the ESC Press Office.
For independent comment on site, please contact Kate Rees on +336 33 80 35 07.

Notes to editor

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 68,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2011
ESC Congress 2011 will take place from 27 to 31 August at the Parc des Expositions - Paris Nord Villepinte, France. Information on the scientific programme is available here. More information on ESC Congress 2011 is available from the ESC Press Office or contact us at press@escardio.org


References This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2011.



Hot Line III - Acute coronary syndromes
CRISP AMI: A multi-center, randomized, controlled study of mechanical left ventricular unloading with Counterpulsation to Reduce Infarct size pre-PCI for Acute Myocardial Infarction: rationale and design of the CRISP AMI trial
 

Edited by the ESC from material supplied by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the investigator.